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PEP-CMV Vaccine for Pediatric Brain Tumors

This study is testing a vaccine called PEP-CMV, along with Temozolomide (a chemotherapy drug) and a Tetanus Diphtheria vaccine, for children and young adults aged 3 to 39. It's for those newly diagnosed with high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG), and for those with medulloblastoma that has come back (recurrent medulloblastoma). The PEP-CMV vaccine works by using your body's immune system (immunotherapy) to fight the cancer. Researchers want to see if this treatment can help patients live longer without their cancer getting worse, or help them live longer overall. The study is currently unclear on its status and aims to enroll 120 participants.

Study design
This is a phase II interventional study with three groups, each focusing on a different type of brain tumor. It plans to enroll 120 participants.
What's involved
Patients will receive the PEP-CMV vaccine, Temozolomide for 5 days in the first cycle, and a Tetanus Diphtheria vaccine. The first cycle of treatment lasts about 77 days.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long patients with recurrent medulloblastoma live without their disease worsening for 4 months. For newly diagnosed DIPG and HGG, it will measure overall survival and progression-free survival for one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05096481

PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma

Recruiting
PHASE2Ages 3–39InterventionalTreatment
Nationwide Children's Hospital
~120 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:PEP-CMVTemozolomideTetanus Diphtheria Vaccine

At a glance

Recruiting sites
10 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
4-mo PFS in patients with recurrent medulloblastoma
Measured over 4 months
+2 more outcomes measured

Conditions

High Grade Glioma
Diffuse Intrinsic Pontine Glioma
Recurrent Medulloblastoma

Explore related trials

Diffuse Intrinsic Pontine GliomaMalignant GliomaMedulloblastoma

Where it's being run

13 sites across 12 states
Ohio2
Colorado1
District of Columbia1
Florida1
Illinois1
Massachusetts1
Michigan1
Missouri1

Study leadership

  • Daniel Landi, MD · STUDY_CHAIR · Duke Cancer Center
  • Eric M Thompson, MD · STUDY_CHAIR · Washington University - St. Louis Children's Hospital
  • Maryam Fouladi, MD · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital

Who to contact

Kelsey H Troyer, PhD
[email protected]
6147223284
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Craniospinal irradiation, total body irradiation or radiation to ≥ 50% of pelvis \> 3 months prior to enrollment.
Focal irradiation \> 4 weeks prior to enrollment 2. Myelosuppressive anticancer therapy: Patients must have received their last dose of myelosuppressive anticancer therapy at least 21 days prior to enrollment 3. Immunotherapy: Patients must have received their last dose of any immunotherapy agents at least 30 days prior to enrollment 4. Non-myelosuppressive anticancer agents: Patients must have received their last dose of non-myelosuppressive anticancer agents at least 7 days prior to study enrollment. 5. Antibodies: Patients must have received their last dose of any antibodies at least 21 days prior to enrollment. 6. Hematopoietic growth factors: Patients must have received their last dose of hematopoietic growth factors at least 14 days prior to enrollment for a long-acting growth factor (e.g. pegfilgrastim) or 7 days prior to enrollment for short-acting growth factor. 7. Autologous stem cell infusion: At least 90 days must have elapsed after an autologous stem cell infusion 6. Organ Function Requirements:
ANC (Absolute neutrophil count) ≥ 1000/µl.
Platelets ≥ 100,000/µl. (may be supported)
Hemoglobin \> 8 g/dL. (may be supported) 2. Adequate Renal Function defined as: Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 or A serum creatinine based on age/gender as follows:
2 to \< 6 years: 0.8 (Male) 0.8 (Female)
6 to \< 10 years: 1 (Male) 1 (Female)
10 to \< 13 years: 1.2 (Male) 1.2 (Female)
13 to \< 16 years: 1.5 (Male) 1.4 (Female)
≥ 16 years: 1.7 (Male) 1.4 (Female) 3. Adequate Liver Function Defined as
Total bilirubin ≤1.5 times institutional ULN
AST(SGOT) ≤3 × institutional upper limit of normal
ALT(SGPT) ≤3 × institutional upper limit of normal 4. Adequate Neurological Function Defined as
Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to enrollment.
Patients with current seizure disorders may be enrolled if seizures are well- controlled on antiepileptic therapies. 5. Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for three months after drug cessation. 6. Signed informed consent according to institutional guidelines must be obtained prior to enrollment.
Patients with a newly-diagnosed HGG must enroll within 6 weeks of their final dose of standard radiation therapy with or without chemotherapy.
Patients with primary spinal cord tumors are eligible 2. Stratum III: Patients with a newly-diagnosed DIPG:
Patients with a radiographically typical DIPG, defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons, are eligible without histologic confirmation.
Patients with brainstem lesions that do not meet these radiographic criteria will be eligible if there is histologic confirmation of an infiltrating astrocytoma WHO grades II-IV. 3. Metastatic Disease: Patients with M+ disease are eligible. 4. Performance Status:
AST(SGOT) ≤3 × institutional upper limit of normal
ALT(SGPT) ≤3 × institutional upper limit of normal 4. Adequate Neurological Function Defined as:

What this trial measures

  • 4-mo PFS in patients with recurrent medulloblastoma4 months

    To determine the progression-free survival (PFS) at 4 months in pediatric or young adult patients with recurrent medulloblastoma treated with PEP-CMV.

  • 1-yr OS in patients with newly diagnosed DIPGone year

    To estimate the 1-year Overall Survival (OS) distribution in patients with newly diagnosed DIPG treated with radiotherapy followed by PEP-CMV

  • 1-yr PFS in patients with newly diagnosed HGGone year

    To estimate the 1-year Progression Free Survival (PFS) distribution in patients with newly diagnosed HGG treated with radiotherapy followed by PEP-CMV